Flashback chamber visual enhancement

ABSTRACT

Featured is a medical infusion device for vascular access with enhanced flashback visualization that includes a hub assembly having a flashback chamber. The hub assembly includes a proximal portion, a distal portion and a substantially transparent window section intermediate the proximal portion and distal portion. A needle is coupled to the flashback chamber so that fluid flows through the lumen of the needle into the flashback chamber after the needle is inserted into a blood vessel. A contrasting member is disposed on at least a portion of the hub assembly, so that when blood enters the flashback chamber, the contrasting member provides a high-contrast background when viewed through the window section.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/904,466, filed Sep. 27, 2007, now U.S Pat. No. 7,833,201 which claimspriority from U.S. Provisional Application Ser. No. 60/848,250 filedSep. 29, 2006, the entire contents of each of which are incorporatedherein by reference.

FIELD OF DISCLOSURE

The present disclosure relates to medical infusion or access devicessuch as intravenous (IV) catheters and more particularly to a vascularaccess device including a chamber for increased visualization of fluidwhen an intravenous catheter is inserted into the vasculature or bloodvessel of the patient.

BACKGROUND INFORMATION

Over-the-needle catheters or over-the-needle IV catheters (such as thatdescribed in U.S. Patent Publication No. 2005-0096592, filed Oct. 31,2003 to Carlyon et al.) are used for peripheral intravenous entry intothe vasculature of a patient. The disposable medical product is packagedas an assembly of a catheter adapter with its catheter, and a needle/hubassembly that is arranged with respect to the catheter adapter so theneedle passes through the catheter tube. The needle also extends aslight distance beyond the distal tip of the catheter tube so as toprovide a sharpened point for penetration through the skin of the humanor animal being catheterized.

After the catheter adapter with its catheter, and a needle/hub assemblyare inserted into the vasculature or blood vessel of the patient, bloodflows due to the vascular blood pressure through the hollow needle andinto the needle hub, sometimes referred to as flashback. Typically, theneedle hub is arranged and configured so the medical personnel areprovided a visual indicator of the blood flashback. This visualindicator is used to indicate that the tip of the needle and thus thedistal end of the catheter tube is disposed in the blood vessel. In onetechnique, the needle hub includes a chamber that is fluidly coupled tothe needle and is made at least in part of a transparent material sothat the blood flashback into the chamber is visually apparent to themedical personnel.

Even though such chambers are transparent, blood in the flashbackchamber of these devices can sometimes be difficult to visualize incertain situations such as low light conditions or against darkerbackgrounds. It thus would be desirable to provide a new vascular accessdevice such as an IV catheter device with enhanced flashbackvisualization. It would be particularly desirable to provide such adevice that provides a high-contrast background to maximize flashbackvisibility. It would be further desirable to provide a device thatfacilitates earlier detection of blood or other fluids in the flashbackchamber with greatly improved flashback visibility when used in lowlight situations or on patients with dark complexions. It also would bedesirable to provide such a device that is less complex in structure,manufacture and operation as compared to prior art devices. Also itwould be desirable that such methods would not require users to havehigher skills than those who ordinarily use such catheter devices.

SUMMARY OF THE INVENTION

The present invention is a medical infusion device for vascular accesswith enhanced flashback visualization. In one embodiment, the deviceincludes a hub assembly having a flashback chamber. The hub assembly hasa proximal portion, a distal portion and a substantially transparentwindow section disposed between the proximal portion and distal portion.A needle that includes a lumen is coupled to the flashback chamber sothat fluid, such as blood, flows through the lumen of the needle intothe flashback chamber after the needle is inserted into a blood vessel.A contrasting member is disposed on at least a portion of the hubassembly, so that when blood enters the chamber, the member provides ahigh-contrast background when viewed through the window section.

The present invention provides a device that is less complex instructure, manufacture and operation as compared to prior art devices.These and other objects and advantages of the invention will becomeapparent upon reading the following detailed description and claims, andupon reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature and desired objects of thepresent disclosure, reference is made to the following detaileddescription taken in conjunction with the accompanying drawing figureswherein like reference characters denote corresponding parts throughoutthe several views and wherein:

FIG. 1A is a perspective view of a medical device according to anexemplary embodiment of the present disclosure;

FIG. 1B is a schematic top view of the medical device shown in FIG. 1A;

FIG. 1C is a schematic side view of the medical device shown in FIG. 1A;

FIG. 1D is an exploded perspective view of the medical device shown inFIG. 1A;

FIG. 1E is an exploded top view of a medical device shown in FIG. 1B;

FIG. 2A is a side view of a needle according to an exemplary embodimentof the present disclosure;

FIG. 2B is a top view of the needle shown in FIG. 2A;

FIG. 2C is a front view of the needle shown in FIG. 2A;

FIG. 2D is a cross-sectional view of the needle shown in FIG. 2B takenalong the section line 2D-2D of FIG. 2B;

FIG. 2E is an enlargement of area 2E shown in FIG. 2B;

FIG. 2F is an enlargement of area 2F shown in FIG. 2B;

FIG. 2G is an enlarged perspective view of an alternative exemplaryembodiment of a needle slidably mounted in a catheter with perforationsnear the distal end;

FIG. 2H is a cross sectional view of the enlarged view of FIG. 2G;

FIG. 2I is an enlarged perspective view of an alternative exemplaryembodiment of a needle slidably mounted in a catheter with corrugationsalong the exterior of the needle and/or the interior of the catheter;

FIG. 2J is a cross sectional view of the enlarged view of FIG. 2I;

FIG. 3A is a perspective view of a hub assembly according to anexemplary embodiment of the present disclosure;

FIG. 3B is a front view of the hub assembly shown in FIG. 3A;

FIG. 3C is a top view of the hub assembly shown in FIG. 3A;

FIG. 3D is a side view of the hub assembly shown in FIG. 3A;

FIG. 3E is a cross-sectional view of the hub assembly shown in FIG. 3Ctaken along section line 3E-3E of FIG. 3C;

FIG. 3F is a front view of the hub assembly shown in FIG. 3B rotated 90degrees counterclockwise;

FIG. 3G is a cross-sectional view of the hub assembly shown in FIG. 3Ftaken along section line 3G-3G of FIG. 3F;

FIG. 3H is a cross-sectional view of the hub assembly shown in FIG. 3Ftaken along section line 3H-3H of FIG. 3F;

FIG. 3I is a back view of the hub assembly shown in FIG. 3A;

FIG. 3J is a perspective view of the hub assembly shown in FIG. 3A witha needle hub in place;

FIG. 3K is a front view of the hub assembly shown FIG. 3J;

FIG. 3L is a top view of the hub assembly shown in FIG. 3J;

FIG. 3M is a side view of the hub assembly shown in FIG. 3J;

FIG. 3N is a cross-sectional view of the hub assembly shown in FIG. 3M;

FIG. 3O is a back view of the hub assembly shown in FIG. 3A;

FIG. 3P is a perspective view of a needle hub;

FIG. 4A is aperspecive view of a filter housing according to anexemplary embodiment of the present invention;

FIG. 4B is a side view of the filter housing shown in FIG. 4A;

FIG. 4C is a back view of the filter housing shown in FIG. 4A;

FIG. 4D is a cross-sectional view of the filter housing shown in FIG. 4Ctaken along section line 4D-4D of FIG. 4C;

FIG. 4E is a perspective view of filter plug according to an exemplaryembodiment of the present disclosure;

FIG. 5A is a perspective view of a hub assembly according to anexemplary embodiment of the present disclosure;

FIG. 5B is a front view of the hub assembly shown in FIG. 5A;

FIG. 5C is a top view of the hub assembly shown in FIG. 5A;

FIG. 5D is a cross-sectional view of the hub assembly shown in FIG. 5Ctaken along the line B-B;

FIG. 5E is a cross-sectional view of the hub assembly shown in FIG. 5Ctaken along the line A-A;

FIG. 5F is a side view of the hub assembly shown in FIG. 5A;

FIG. 5G is a bottom view of the hub assembly shown in FIG. 5A;

FIG. 5H is a back view of the hub assembly shown in FIG. 5A;

FIG. 5I is a front view of the hub assembly shown in FIG. 5B rotated 90degrees counterclockwise;

FIG. 5J is a cross-sectional view of the hub assembly shown in FIG. 5Itaken along the line E-E;

FIG. 5K is a cross-sectional view of the hub assembly shown in FIG. 5Itaken along the line F-F;

FIG. 5L is a cross-sectional view of the hub assembly shown in FIG. 5Ktaken along the line G-G;

FIG. 5M is a cross-sectional view of the hub assembly shown in FIG. 5Ktaken along the line H-H;

FIG. 5N is an enlarged cross-sectional view of a portion of the hubassembly shown in FIG. 5K;

DEFINITIONS

The following definitions are for convenient reference with respect tothe following description and are not to be construed in a limitingmanner.

The term “proximal” shall be understood to mean or refer to a locationon the device, object or part being discussed which is closest to themedical personnel and farthest from the patient in connection with whomthe device is used when the device is used in its normal operation, or adirection toward the medical personnel and away from the patient.

The term “distal” shall be understood to mean or refer to a location onthe device, object or part being discussed which is farthest from themedical personnel and closest to the patient in connection with whom thedevice is used when the device is used in its normal operation, or adirection away from the medical personnel toward the patient.

The term “medical personnel” shall be understood to be generallyinclusive of clinicians, surgeons, medical technicians, lab technicians,nurses, nurse practitioners, physician's assistants, veterinarians andveterinary assistants, or other persons who are involved with the use ofmedical infusion or access devices.

The term “patient” shall be understood to include both humans andanimals and also shall be inclusive of humans or animals that areundergoing medical procedures including but not limited to surgicalprocedures and diagnostic procedures, medical treatment and/or othertechniques/procedures/treatments performed in hospitals, clinics,doctor's offices, diagnostic facilities/laboratories or the like, whichinvolve use of medical infusion or access devices.

DETAILED DESCRIPTION

In its broadest aspects, the present disclosure features vascular accessdevices with enhanced flashback visualization and methods of using suchdevices. The exemplary embodiments of the device with enhanced flashbackvisualization and methods of using such devices are discussed in termsof medical access devices such as, for example, infusion devices,over-the-needle catheters, other catheters and feeding tubes used foradministration of fluids to patients. It is envisioned, and is thuswithin the scope of the present invention, for such a device to beadapted for use with a wide variety of medical devices for the infusionof medications and therapeutics to a patient. It is also envisioned thatthe present invention is used for the collection of body fluidsincluding those collected during procedures relating to phlebotomy,digestive, intestinal, urinary and lumbar puncture. All relativedescriptions herein such as top, bottom, left, right, up, and down arewith reference to the figures, and thus should not be construed in alimiting sense.

Referring to FIGS. 1A-1E, there is shown a vascular access device 10with enhanced flashback visualization according to a first exemplaryembodiment of the present disclosure. As indicated above, the vascularaccess device 10 allows medical personnel to more easily visualize bloodflashback to ensure proper placement of a catheter in the blood vessel(e.g., vein or artery) of a patient. The vascular access device 10includes a catheter 12 having a proximal end 14, a distal end 16 anddefining a lumen 18. A needle 20 having a proximal end 22 and a distalend 24 is slidably mounted in the lumen 18 of the catheter 12.

Referring now to FIGS. 2A-2F, the distal end 24 of the needle 20 issharpened to a point 26 which protrudes a slight distance past thedistal end 16 of the catheter 12 (FIG. 1C). The sharpened point 26punctures the skin and blood vessel of a patient and allows the distalend 24 of the catheter 12 to be inserted into the patient's bloodvessel. The needle 20 includes a lumen 28 extending from a distalopening 30 to a proximal opening 34. The needle 20 also defines a notchopening 32 (FIG. 2E) that is near but spaced apart from the distalopening 30. Upon insertion of the distal end 24 of the needle 20 intothe patient's blood vessel, blood flows into the distal opening 30, upthrough the lumen 28 and then out through the notch opening 32 and theproximal opening 34. The blood exiting the notch opening 32 flows intoan annular space (not shown) between the needle 20 and the catheter 12.This blood exiting into the annular space provides an early indicationto the medical personnel that a blood vessel has been punctured.

Referring now also to FIGS. 2G and 2H, there is shown an alternateexemplary embodiment for providing medical personnel with an earlyindication that a blood vessel has been punctured. In this exemplaryembodiment the distal end 16 of the catheter 12 includes perforations 80through the catheter 12 wall allowing fluid outside the catheter 12 tobe put in fluid communication with the annular space 82 between theneedle 20 and the catheter 12. Thus, when the catheter distal end 16 islocated within the blood vessel, blood can flow through the perforations80 into the annular space 82.

Referring now also to FIGS. 2I and 2J, there is shown yet anotheralternative exemplary embodiment for providing medical personnel with anearly indication that a blood vessel has been punctured. In thisexemplary embodiment, bumps or corrugations 84 are provided on theexterior surface of the needle 20 and/or the interior surface of thecatheter 12 so that a flow path is established between the vessel andthe annular space 82, thereby allowing fluid to flow into the annularspace 82. It will be apparent to one skilled in the art that otherfabrication techniques also would be appropriate to provide an earlyindication that a blood vessel has been punctured.

It is contemplated that the needle 20 can be any type of needleincluding, for example, a thoracentesis needle, Veress needle, or Huberneedle. It is envisioned that the needle 20 can be fabricated fromstainless steel in a range of sizes, including, but not limited to,about 14 to 26 gauge, although smaller or larger sizes can be useddepending on the requirements of a particular application. The needle 20can also be provided in various lengths, for example, about 2.2 to 3.6inches, although shorter or longer lengths are also envisioned.

The proximal end 22 of the needle 20 is connected to the hub assembly 36(FIG. 1A). Referring now to FIGS. 3A-3P, the hub assembly 36 defines areceptacle (FIG. 3A) and is generally rectangular in cross section,having two sides 70, 72, a top 74 and a bottom 76, and includes windowsection 42. The hub assembly 36 further includes a needle hub 40 (FIG.3P) received within the receptacle (FIGS. 3J and 3L-3N) adapted toselectively secure the proximal end 22 of the needle 20 to the hubassembly 36. The needle hub 40 includes a cavity or a flashback chamber38. The needle 20 is received through an inlet 43 in the needle hub 40and fluidly coupled to the flashback chamber 38 (FIG. 3N). It isenvisioned that the proximal end 22 of the needle 20 (FIG. 1D) willprotrude about 0.0 to 2.0 millimeters into the flashback chamber 38,although greater protrusion is acceptable. When the medical personnelinsert the needle 20 into a blood vessel, the blood flows into thedistal opening 30, up through the lumen 28 and then out through theproximal opening 34 into the flashback chamber 38. As a result, themedical personnel can visualize blood entering the flashback chamber 38through the window section 42 and are provided with a visual indicationthat the needle 20 is properly positioned in the blood vessel. It isalso envisioned that the window section 42 can be convex, or curved insuch a way to magnify the blood in the flashback chamber 38.

The hub assembly 36 including the needle hub 40 are fabricated frommaterials suitable for medical applications, such as, for example,semi-rigid and rigid polymerics as well as resilient materials, such asmolded medical grade polypropylene. It is also envisioned that the hubassembly 36 can be fabricated from a transparent (or clear)bio-compatible plastic, so that when blood enters the flashback chamber38, it can be easily visualized by the medical personnel. One skilled inthe art will realize that other materials and fabrication methods alsowould be appropriate. The hub assembly 36 also can be semi-transparent,translucent or opaque, provided however, window section 42 of the hubassembly 36 is transparent, or substantially transparent so that bloodflashback can be easily visualized in the flashback chamber 38.

Referring now to FIG. 4A-4E, the hub assembly 36 (FIG. 1D) furtherincludes a filter housing 46. The filter housing 46 is generally tubularand defines an outlet 48 fluidly coupled to the flashback chamber 38 toallow air to escape therefrom. In an exemplary embodiment, the filterhousing 46 includes a filter plug 52 (FIG. 4E) disposed in the outlet48. The filter plug 52 can be made from a number of materials known inthe art which allow air to pass through, but are impermeable orsemi-impermeable to liquids such as blood, so that the blood isprevented from leaking out of the flashback chamber 38. As shown, thefilter housing 46 is tubular, although other shapes and sizes will beapparent to one skilled in the art depending on the requirements of anyparticular application. It is envisioned, and thus within the scope ofthe present disclosure that the entire hub assembly 36 can be fabricatedin one piece or in multiple components. The multiple components, forexample, a handle, needle hub and filter housing, are then assembled andheld together with mechanical fasteners, heat or ultrasonic welding,adhesives, or by other means or techniques known to those skilled in theart. A multiple component hub assembly 36 provides many advantages,including, for example, simpler and more flexible methods ofmanufacturing various size IV catheters.

The foregoing is illustrative and is not limiting, as it would beapparent to one skilled in the art that any number of structures ordevices can be used to create a barrier that is impermeable orsemi-impermeable to liquids but which is gas permeable. For example, thefilter housing outlet 48 can be capped off and the mechanism capping offthe outlet 48 can include a plurality of through apertures that aresized so as to have the above desired gas permeable/liquid impermeablecharacteristics.

Referring now to FIGS. 5A-5N, a contrasting member 54 can be disposed onthe hub assembly 36 to provide a high-contrast background to enhancedetection and visibility of blood or other body fluids in the flashbackchamber 38. This contrasting member 54 provides many advantages,including, for example, earlier, easier, and more definitive detectionof blood in the flashback chamber 38. Visualization of blood in theflashback chamber provides an indication to the medical personnel thatthe distal end 24 of the needle 20, and thus the distal end 16 of thecatheter 12, has penetrated a blood vessel of the patient. In anillustrative exemplary embodiment, the contrasting member 54 is opaque,white and uniformly disposed on the hub assembly 36. It is envisioned,and thus within the scope of the present disclosure that the color,transparency, reflectance, and coverage of the contrasting member 54 isgenerally selected so as to provide an effective background for the typeof fluid that would appear in the flashback chamber 38.

The hub assembly 36 includes depressed regions or hollows 56 formed onone or both opposing sides 70, 72 to allow for digit placement by themedical personnel. The contrasting member 54 is substantially disposedon both hollows 56, and the bottom 76 of the hub assembly 36. As shownin FIG. 5F, the contrasting member 54 further includes alternatingraised portions 60 and indented portions 62 to provide a more securegripping surface or grip for the medical personnel. In furtherembodiments, the contrasting member 54 can be disposed on any portion ofthe hub assembly 36. Additional examples and patterns of contrastingmembers 54 will be apparent to one skilled in the art.

In one embodiment, the contrasting member 54 is disposed on at least aportion of the hub assembly 36 opposite the medical personnel's line ofsight, such that when viewing through the window section 42, thecontrasting member 54 provides the desired contrast at a variety ofviewing angles. In the illustrated embodiment, the medical personnelwould place their thumb and finger in the hollows 56 of the hub assembly36 when inserting the medical device into a patient. The medicalpersonnel may then visualize the flashback chamber 38 through the windowsection 42 of the hub assembly 36.

In particular embodiments, the contrasting member 54 is an integral partof the hub assembly 36, or is secured/applied to the surface(s) thereof.Numerous materials and fabrication techniques will be apparent to oneskilled in the art including, for example, molding, injection molding,two-shot molding, over-molding, printing, painting and adhesivelabeling. It is envisioned, and is thus within the scope of the presentdisclosure, for such fabrication techniques to include processes wherebythe molded material has a translucent or opaque region sufficient toprovide a high contrast background. It is also envisioned that thecontrasting member 54 is a separate component part (e.g., a molded part)that is then secured to the hub assembly 36. It will be apparent to oneskilled in the art that a separate contrasting member 54 can be securedto the hub assembly 36 in any of a number of ways including, forexample, snap on, mechanically fastened, heat welding, vibrationwelding, ultrasonically welding, or boding with an adhesive.

It is also envisioned that one or more surfaces of the hub assembly 36and/or needle hub 40 can be treated or processed (e.g., chemicallyetched, sand blasted, etc.) so as to provide a surface finish thatcreates a contrasting surface. In further embodiment, such a surfacefinish or treatment is achieved by use of an appropriate manufacturingtechnique (e.g., molding the part using a mold including a texturedsurface so that the part is formed with a textured translucent surface).

In alternative embodiments, the contrasting member can be intermittentlydisposed on the hub assembly 36 (e.g., the contrasting member could beformed with raised sections 60 but without the interconnecting indentsections 62). The intermittent sections of contrasting member can beraised from the surface of the hub assembly 36 to provide a more securegrip for the medical personnel. Medical personnel sometimes place theirthumb or finger on the top 74 and the bottom 76 of the hub assembly 36when inserting the medical device 10 into a patient. In this alternativeembodiment, the intermittent sections of contrasting member allows themedical personnel to visualize blood entering the flashback chamber 38through the alternating transparent regions of the hub assembly 36 andopaque regions of the contrasting member.

In operation, the medical personnel grips the vascular access device 10by placing a thumb and finger in the hollows 56 of the hub assembly 36and inserts the sharpened point 26 of the needle 20 into the bloodvessel of a patient. Once the distal end 24 of the needle 20 punctures ablood vessel, blood will begin to flow in to the lumen 28 at leastthrough capillary action and/or due to vascular pressure. Blood willfirst flow through the notch opening 32, perforations 80, orcorrugations 84 into the annular space 82 between the needle 20 and thecatheter 12, providing an early indication to the medical personnel thata blood vessel has been punctured. As the distal end 24 of the needle 20and the distal end 16 of the catheter 12 are further inserted into theproper location of the blood vessel, vascular blood pressure pushesblood up through the lumen of the needle and eventually out of theproximal end 22 of the needle 20 into the flashback chamber 38. The airin the flashback chamber 38 also passes through the filter plug 52, forexample to facilitate the flow of blood into the flashback chamber. Asthe filter plug 52 is impermeable to liquids such as blood, the blood isprevented from leaking out of the flashback chamber 38.

As blood enters the flashback chamber 38, the medical personnelvisualize the blood through the window 42 and against the contrastingmember 54 instead of other backgrounds such as, for example, the skin ofthe patient as in conventional devices which can be dark with minimalcontrast if the patient is bruised or has a dark complexion.Additionally, visualization of blood may be provided by viewing throughthe proximal region of the needle hub 40 (FIG. 3P), which extendsproximally beyond the window section 42. Consequently, the medicalpersonnel are provided with visual indication that the catheter 12 isproperly positioned in the blood vessel.

Although the embodiments of the disclosure have been described usingspecific terms, such description is for illustrative purposes only, andit is to be understood that changes and variations may be made withoutdeparting from the spirit or scope of the following claims.

INCORPORATION BY REFERENCE

The entire contents of all patents, published patent applications andother references cited herein are hereby expressly incorporated hereinin their entireties by reference.

1. A medical infusion device for vascular access with enhanced flashback visualization, comprising: a hub assembly defining a receptacle, the hub assembly having a substantially transparent window section; a needle hub at least partially disposed within the receptacle of the hub assembly, the needle hub defining a flashback chamber disposed within the hub assembly, the flashback chamber being made at least in part of a transparent material; a contrasting member disposed on at least a portion of the hub assembly, wherein the contrasting member is snapped onto the hub assembly; and a filter housing fluidly coupled to the flashback chamber, the filter housing including a filter plug.
 2. The medical infusion device of claim 1, wherein the contrasting member is a patterned member allowing for improved grip by a user.
 3. The medical infusion device of claim 1, wherein the contrasting member is opaque and white.
 4. The medical infusion device of claim 1, wherein the filter plug includes a gas-permeable, liquid-impermeable material.
 5. A medical infusion device for vascular access with enhanced flashback visualization, comprising: a hub assembly defining a receptacle, the hub assembly having a substantially transparent window section; and a needle hub at least partially disposed within the receptacle of the hub assembly, the needle hub defining a flashback chamber disposed within the hub assembly, the flashback chamber being made at least in part of a transparent material, wherein the window section exhibits an arcuate configuration to provide a magnifying view of fluid in the flashback chamber.
 6. The medical infusion device of claim 5, wherein the window section defines a convex configuration.
 7. A medical infusion device for vascular access with enhanced flashback visualization, comprising: a hub assembly defining a receptacle, the hub assembly having a substantially transparent window section; a needle hub at least partially disposed within the receptacle of the hub assembly, the needle hub defining a flashback chamber disposed within the hub assembly, the flashback chamber being made at least in part of a transparent material; and a contrasting member disposed on at least a portion of the hub assembly, wherein the contrasting member is snapped onto the hub assembly.
 8. The medical infusion device of claim 7, wherein the contrasting member is a patterned member allowing for improved grip by a user.
 9. The medical infusion device of claim 7, wherein the contrasting member is opaque and white. 